Duns Number:500375274
Device Description: The Magstim TMS Patient Caps are non-sterile medical device accessories, intended to aid i The Magstim TMS Patient Caps are non-sterile medical device accessories, intended to aid in landmark registration during TMS procedures. The user will mark the cap to record various landmarks associated with the treatment or therapy they are conducting.
Catalog Number
-
Brand Name
Magstim TMS Patient Cap (Size Large)
Version/Model Number
5772-00
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FYF
Product Code Name
Cap, Surgical
Public Device Record Key
c2a41a5d-8ee3-446d-95f0-5df2ef8417a9
Public Version Date
February 08, 2022
Public Version Number
1
DI Record Publish Date
January 31, 2022
Package DI Number
15060229532777
Quantity per Package
10
Contains DI Package
05060229532770
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |